NCT06659913

Brief Summary

The association between adequate amount of physical activity and good health is well established and for children and young people, and sufficient physical activity is an important factor for normal growth and development. Contrary, physical inactivity is associated with higher symptom pressure of mental disorders. Adolescents with mental disorders report to be less active compare the general population, with potentially increased risk of health and lifestyle diseases. This project aims to provide new knowledge on the degree of physical activity, motivation for physical activity and subjective perception of health in adolescents in need of mental health care. Further, this project aim to provide possible solution on how to increase physical activity in this patient group. Thus, this project has the potential to impact future guidelines for mental health services for adolescents in need of mental health care.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

March 13, 2023

Last Update Submit

October 24, 2024

Conditions

Mental Health Impairment

Outcome Measures

Primary Outcomes (1)

  • Physical activity level

    Obejctively measured total physical activity level

    after 12 weeks intervention

Secondary Outcomes (2)

  • Psychiatric symptom pressure and quality of life

    after 12 weeks intervention

  • Physical activity level, Psychiatric symptom pressure and quality of life

    6 months after intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants in the exercise group will be encouraged to follow the Norwegian Health authority's recommendation of being physically active for an average of 60 minutes a day, but they will also be offered a three-part intervention as a supplement to ordinary treatment. Supervised exercise will be offered once a week and they're encouraged to perform two additional exercise sessions per week.

Behavioral: Exercise training

Control group

ACTIVE COMPARATOR

The control group will receive treatment as usual

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

Session 1: Consist of high intensity interval training performed on spinning bikes. An exercise physiologist will supervise the participants to perform a light 10 min warm-up, followed by 4 min working periods (intervals) interspersed by 3 min active breaks. The intensity should be 85-95% of estimated peak heart rate, corresponding to approximately 16 on the Borg scale (17). There will be a maximum of 10 participants in each group, depending on how many patients who are recruited for each of the two inclusion periods.I In addition, participants are encouraged to participate in the physical education at school and encouraged to perform exercise during the weekend, either with their family or friends.

Control groupIntervention group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,

Trondheim, 7006, Norway

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dorthe Stensvold Stensvold

    Dorthe Stensvold, Professor, NTNU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorthe Stensvold

CONTACT

4792092856dorthe.stensvold@ntnu.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

October 26, 2024

Study Start

April 13, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

October 26, 2024

Record last verified: 2024-10

Locations

NO(1)